GMP Quality Lead & Compliance Champion

Smart Media; Suffolk (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Smart Media in Suffolk, VA is seeking a Quality Lead to ensure cGMP compliance across documentation, deviations, CAPAs, change controls, audits and continuous improvement initiatives. This role supports an inspection-ready Quality Management System in an individual contributor capacity with growth potential into people leadership.

The position involves managing GMP documents, drafting SOPs, maintaining QA databases, coordinating investigations, and supporting vendor qualifications and audits.

Qualifications

• Bachelor's degree in Life Sciences or related field with 5+ years in pharma.
• Audit experience with regulatory bodies is preferred.
• Experience in distribution quality operations and managing contract manufacturers.
• Experience with quality systems in warehouse/contract manufacturing environments.

Responsibilities

• Manage lifecycle of controlled GMP documents with version control and archival.
• Author, review, and maintain SOPs, reports, batch records, and forms.
• Maintain QA databases and document repositories in inspection-ready state.
• Track and review change requests and required records for timely completion.
• Ensure compliance with cGMP, DEA, SOPs and regulatory requirements.
• Support QMS including deviations, CAPAs, change controls, investigations, and closures.
• Coordinate investigations, non-conformances, and customer complaints for root causes.
• Support inspections, sampling, shipment review, and material disposition.
• Assist warehouse and distribution quality activities and environmental monitoring.
• Participate in audits, vendor qualifications, validation, and APQRs.
• Identify quality risks and support continuous improvement and training.

Skills

cGMP compliance

QMS processes

Pharma warehouse knowledge

TrackWise/Veeva

Analytical writing/communication

Education

Bachelor's degree in Life Sciences or related field

Tools

TrackWise

Veeva

MS Office

Job description

Smart Media in Suffolk, VA is seeking a Quality Lead to ensure cGMP compliance across documentation, deviations, CAPAs, change controls, audits and continuous improvement initiatives. This role supports an inspection-ready Quality Management System in an individual contributor capacity with growth potential into people leadership.

The position involves managing GMP documents, drafting SOPs, maintaining QA databases, coordinating investigations, and supporting vendor qualifications and audits.